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Fatigue and Kinematics During Isometric Activity of the Upper Limbs in Young and Older Adults

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ClinicalTrials.gov Identifier: NCT04938791
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Helena Silva, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa

Tracking Information
First Submitted Date  ICMJE June 4, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date June 24, 2021
Estimated Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    The perceived effort will be measured with Borg CR 10 scale. Possible scores range from 0 (no exertion at all) to 10 (extremely strong).
  • Change from Baseline in heart rate [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Heart rate (heart beatings per minute) measured before and during activity to track cardiovascular changes during activity.
  • Change from Baseline in respiratory rate [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Respiratory rate (respiratory cycles per minute) measured before and during activity to track changes in respiratory function during activity.
  • Change from Baseline in heart rate variability (HRV) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Interval (in milliseconds) between consecutive heartbeats measured before and during activity to track changes in autonomic function during activity.
  • Change from Baseline in electrodermal activity (EDA) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Electrical conductance (in microsiemens -µS) between two points of the hand over time measured before and during activity to track changes in autonomic function during activity.
  • Change from Baseline in muscle action potential amplitude through surface electromyography (sEMG) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Muscle action potential amplitude (in millivolts - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.
  • Change from Baseline in muscle action potential duration through surface electromyography (sEMG) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Muscle action potential duration (in milliseconds - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.
  • Change from Baseline in muscle action potential frequency through surface electromyography (sEMG) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Muscle action potential frequency (in hertz - Hz) of surface electromyographic signal measured before and during activity to track muscular fatigue signs.
  • Change from Baseline in respiratory pattern through inertial motion units (IMU) from baseline and during activity [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Angular range of motion (in degrees) of rib cage and abdominal wall during upper limb activity measured before and during activity to track changes in respiratory pattern during activity
  • Change from Baseline in upper limb motion angular acceleration through inertial motion units (IMU) system [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Angular acceleration (in m/s^2) of the arm measured before and during activity to track small movements of upper limb during isometric activity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Health Status [ Time Frame: Before isometric activity ]
    Health Status will be measured with Medical Outcomes Study (MOS) Short Form Health Survey 36 Item version 2 which measure health status of populations and individuals. Possible scores range from 0 0 (worst health status) to 100 (best health status).
  • Physical activity level [ Time Frame: Before isometric activity ]
    Physical activity level will be measured using European Prospective Investigation into Cancer and Nutrition Physical Activity Questionnaire (EPIC-PAQ) that allows to estimate energy expenditure through self-report assessment of the intensity and average duration (per day, week and month) of physical activity performed by the participants in three distinct dimensions (professional, domestic and leisure). Participants are classified as ACTIVE if they perform: at least 150 minutes per week of moderate physical activity; OR at least 75 minutes per week of vigorous physical activity; OR at least 150 minutes per week of a combination of moderate-intensity activity. If they don't present any of the conditions described, they will be categorized as SEDENTARY.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatigue and Kinematics During Isometric Activity of the Upper Limbs in Young and Older Adults
Official Title  ICMJE Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics
Brief Summary The aim of this study is to understand the relationship between perceived effort and physiological and kinematic variables caused by isometric activity of the upper limbs, as well as its relationship with socio-demographic characteristics, level of activity and quality of life.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Fatigue; Muscle, Heart
Intervention  ICMJE Other: Isometric activity
Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.
Other Name: Isometric task
Study Arms  ICMJE Experimental: Isometric activity
All participants will be included in this arm
Intervention: Other: Isometric activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • Minimum age of 18 years;

Exclusion Criteria:

  • Unable to provide written consent
  • History of heart, cardiovascular and / or respiratory disease,
  • Known untreated hypertension, cardiomyopathy, or exercise intolerance
  • Presence of cognitive or neurological disorders
  • Neuromuscular or orthopaedic disorder that limits the movement of the upper limb to 90° flexion or the maintenance of that position
  • BMI ≥ 40
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Helena Silva Migueis, MSc 917988595 hsilva@esscvp.eu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938791
Other Study ID Numbers  ICMJE ESSCVP_FIS01/2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helena Silva, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
Study Sponsor  ICMJE Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel López López, PhD Universidade da Coruña
PRS Account Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP